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EC number: 246-669-4 | CAS number: 25152-85-6
Positive Control - The Stimulation Index expressed as the mean radioactive incorporation for the treatment group divided by the mean radioactive incorporation of the vehicle control group is as follows:
5% v/v in acetone/olive oil 4:1
10% v/v in acetone/olive oil 4:1
25% v/v in acetone/olive oil 4:1
Clinical Observations, Body Weight and Mortality Data – Preliminary Screening Test
Body Weight (g)
0 = No signs of systemic toxicity
Local Skin Irritation – Preliminary Screening Test
Local Skin Irritation
Measurement of Ear Thickness and Mean Ear Thickness Changes – Preliminary Screening Test
Ear Thickness Measurement (mm)
overall mean (mm)
overall mean ear thickness change (%)
na = not applicable
Individual Disintegrations per Minute and Stimulation Index
Concentration(% v/v) inacetone/olive oil 4:1
Mean dpm/Animal(Standard Deviation)
dpm = Disintegrations per minute
a = Total number of lymph nodes per animal is 2
b = Stimulation Index of 3.0 or greater indicates a positive result
na = not applicable
** = Significantly different from control group p<0.01
*** = Significantly different from control group p<0.001
The Stimulation Index expressed as the mean radioactive incorporation for each treatment group divided by the mean radioactive incorporation of the vehicle control group are as follows:
Concentration (%v/v) inacetone/olive oil 4:1
The skin sensitization potential of the test substance has been tested according to OECD TG 429: “Local Lymph Node Assay” and in compliance with GLP principles. Following a preliminary screening test in which no clinical signs of toxicity were noted at a concentration of 100%, this concentration was selected as the highest dose investigated in the main test of the Local Lymph Node Assay. Based on the anticipated sensitization potential, three groups, each of five animals, were treated with 50 µL (25 µL per ear) of the undiluted test item or the test item as a solution in acetone/olive oil 4:1 at concentrations of 25% or 5% (v/v). A further group of five animals was treated with acetone/olive oil 4:1 alone. At 5, 25 and 100% the substance showed SI values of 1.53; 3.11 and 3.83, respectively. The concentration of test item expected to cause a 3 fold increase in 3HTdR incorporation (EC3 value) was calculated to be 24%. A NOAEC of 5% is derived.
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